AN INTERVENTIONAL PHASE 2, OPEN-LABEL, MULTI-CENTER STUDY TO EVALUATE SAFETY AND EFFICACY OF PF-06835375 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE PRIMARY IMMUNE THROMBOCYTOPENIA
Who is this study for? Adults with moderate to severe primary immune thrombocytopenia
What treatments are being studied? PF-06835375
Status: Recruiting
Location: See all (27) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This is a Phase 2, open-label, multicenter, multiple subcutaneous injection, safety and efficacy study of PF-06835375 in adult participants with primary immune thrombocytopenia (ITP). This study will focus on participants with persistent (\>3 months and ≤12 months), or chronic (\>12 months) ITP
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• Diagnosis of Primary ITP. Ongoing ITP (platelet counts \<50 x 109/L) \[No severe bleeding within 1 month or during screening\] AND Persistent ITP (3 to 12 months) or Chronic ITP \>12 months
Locations
United States
North Carolina
East Carolina University
RECRUITING
Greenville
Other Locations
Australia
Flinders Medical Centre
RECRUITING
Bedford Park
ICON Cancer Centre - Kurralta Park
RECRUITING
Kurralta Park
Liverpool Hospital
RECRUITING
Liverpool
South West Radiology
RECRUITING
Liverpool
The Alfred Hospital
RECRUITING
Melbourne
Slade Pharmacy
RECRUITING
Mount Kuring-gai
Royal Perth Hospital
RECRUITING
Perth
Calvary Mater Newcastle
RECRUITING
Waratah
Canada
McGill University Health Centre
RECRUITING
Montreal
Unity Health Toronto, St. Michael's Hospital
RECRUITING
Toronto
Hungary
Semmelweis University
RECRUITING
Budapest
Petz Aladár Egyetemi Oktató Kórház
RECRUITING
Győr
Somogy Megyei Kaposi Mór Oktató Kórház
RECRUITING
Kaposvár
Pécsi Tudományegyetem Klinikai Központ
ACTIVE_NOT_RECRUITING
Pécs
Tolna Varmegyei Balassa Janos Korhaz
NOT_YET_RECRUITING
Szekszárd
Komárom-Esztergom Vármegyei Szent Borbála Kórház
NOT_YET_RECRUITING
Tatabánya
Poland
InterHem
ACTIVE_NOT_RECRUITING
Bialystok
Klinika Hematologii i Transplantologii Uniwersyteckie Centrum Kliniczne
ACTIVE_NOT_RECRUITING
Gdansk
Pratia Onkologia Katowice
RECRUITING
Katowice
Uniwersytecki Szpital Kliniczny w Poznaniu
ACTIVE_NOT_RECRUITING
Poznan
AIDPORT Sp. z o.o.
RECRUITING
Skórzewo
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
RECRUITING
Wroclaw
United Kingdom
Addenbrooke's Hospital
RECRUITING
Cambridge
Hammersmith Hospital
RECRUITING
London
Derriford Hospital
RECRUITING
Plymouth
The Royal Cornwall Hospital
RECRUITING
Truro
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2022-02-02
Estimated Completion Date: 2028-08-02
Participants
Target number of participants: 91
Treatments
Experimental: Open Label PF-06835375 dose 1 Treatment
subcutaneous injection once monthly for 3 months
Experimental: Open Label PF-06835375 dose 2 Treatment
subcutaneous injection once monthly for 4 months
Experimental: Open Label PF-06835375 dose 3 Treatment
subcutaneous injection once monthly for 4 months
Experimental: Open Label PF-06835375 dose 4 Treatment
subcutaneous injections once monthly for 4 months
Related Therapeutic Areas
Sponsors
Leads: Pfizer